Composite suture needles having elastically deformable sections

ABSTRACT

A composite suture needle configured for passing through a smaller cannula used in minimally invasive surgery includes a curved elongated body made of stainless steel. The curved elongated body has a proximal end and a distal end with a pointed tip. The composite suture needle includes a sheath overlying the curved elongated body. The sheath is curved for conforming to the shape of the curved elongated body. The sheath is made of a material that is more elastic than the curved elongated body. The pointed tip of the curved elongated body extends distally beyond the distal end of the sheath. The curved elongated body is made of stainless steel and the sheath is made of a material, such as nitinol, that is more elastic than the elongated body.

PRIORITY CLAIM

The present application is a Divisional application of U.S. patentapplication Ser. No. 16/845,354 filed on Apr. 10, 2020. The disclosureof the above application is incorporated herein by reference.

BACKGROUND OF THE INVENTION Field of the Invention

The present patent application is generally related to surgicalprocedures and surgical tools, and is more specifically related tosystems, devices and methods of making and using elastic suture needlesthat are passed through lumens such as those associated with trocars andcannulas (hereinafter referred to as cannulas).

Description of the Related Art

Surgeons use lumens such as cannulas to position surgical tools, such assuture needles, at surgical sites. The size of a suture needle that canbe passed through a cannula is limited by the size of the opening in thecannula. In many instances, surgeons desire to use larger curved sutureneedles (i.e., suture needles having a curvature are larger than thecannula opening can accommodate) for closing surgical wounds andrepairing anatomical features, however, passing larger curved sutureneedles through smaller cannulas is difficult.

5 mm cannulas are often used during minimally invasive surgeries (MIS),however, surgeons cannot pass the larger suture needles through the 5 mmcannulas so they are forced to use only smaller suture needles. Thesmaller suture needles are less than optimal because, inter alia, theyoften require a surgeon to make many more passes of the suture needleand suture thread through tissue, which lengthens the surgical procedureand can frustrate the surgeon. Using smaller needles may also produce abite distance that puts the wound or anatomical feature at risk ofdehiscence.

Another drawback of using smaller suture needles is that larger sizedsutures cannot be easily attached to the smaller suture needles. Thisoften forces surgeons to use smaller sized sutures than are required fora suturing operation. Thus, when fine or smaller sized sutures arepassed through tissue with a smaller bite size, a cheese wire effect mayresult, whereby the suture cuts through the tissue that it is intendedto hold.

In an effort to resolve one or more of the above-noted problems,advances have been made to provide suture needles made of superelasticalloys having shape memory properties, which enable a curved sutureneedle to be straightened for being passed through a cannula. When thesuperelastic suture needle is removed from the other end of the cannulafor use at a surgical site, the shape memory properties of the needlereturn it back to the original curved shape.

An alloy commonly referred to as nitinol is often used to makesuperelastic suture needles. Suture needles made of nitinol, however,can be very difficult to process, which results in high production coststhat are often charged to customers, and which could substantially limitthe adoption of nitinol suture needles for minimally invasive surgeries.

In addition, there are many challenges associated with securing suturesto the suture attachment barrels of nitinol suture needles. Thesechallenges include the tendency of the suture attachment barrels ofnitinol needles to spring back after a swaging step, which results inthe formation of a weak attachment between the suture thread and thenitinol suture needle.

Thus, there remains a need for improved suture needles, which exhibitelasticity so that larger suture needles may be passed throughrelatively smaller cannulas (e.g., 5 mm cannulas) for use in surgicalprocedures. There also remains a need for suture needles that may bepassed through smaller cannulas and not be plastically deformed. Inaddition, there is a need for systems, devices and methods of makinglarger suture needles made predominantly of stainless steels that can beelastically deformed for passing through the relatively smaller cannulasfor use in minimally invasive surgery.

SUMMARY OF THE INVENTION

Introducing curved suture needles into a minimally invasive surgicalfield is challenging. When the curved suture needle is introducedthrough a device having a lumen, such as a cannula, the size of thecurved suture needle is typically limited to a profile that is smallerthan the inner diameter of the cannula. One way to introduce a largerneedle through a smaller cannula is to flex or bend the needle into aprofile that will fit within the inner diameter of the cannula. Thistypically results in the curved suture needle undergoing a degree ofplastic deformation, however, which requires the suture needle to bere-shaped after it enters the surgical site and before it may be used insuturing.

Another approach is to fabricate a suture needle that is made entirelyfrom a superelastic material such as nitinol (i.e., a metal alloy madeof nickel and titanium). In doing so, however, the resulting sutureneedle is not as strong as suture needles made from more commonly usedmaterials (e.g., 455, 420, 300 series alloys or custom alloys such astungsten-rhenium alloys), and thus the suture needle is not optimal forsubsequent suturing procedures. Moreover, substantial challenges existin the processing of nitinol alloy suture needles including pointgrinding, curve-setting, hole drilling, electro polishing and sutureattachment. Attempts to overcome the above-identified challengestypically result in the production of poor quality and/or high costsuture needles.

Most materials can withstand a modest degree of strain before becomingplastically deformed. A highly elastic material (i.e. those alloysexhibiting a high Yield Strain) will withstand more strain, as comparedto a less elastic material, before becoming plastically deformed. In oneembodiment, a composite suture needle includes a highly elastic materialat the greatest distances from the neutral axis, which will be able towithstand more flexing before becoming plastically deformed as comparedto a suture needle made from a single, less elastic material havinguniform elastic properties. This is because the outer diameter of thecore material is smaller than the actual outer diameter of the compositesuture needle.

In one embodiment of the present patent application, a suture needle maybe manufactured, at least in part, from a core wire stock including acore section made of a strong alloy (e.g., stainless steels includingmartensitic-aged alloys such as ETHALLOY® Needle Alloy, or 455, 420, 300or other custom alloys) and a second material having highly elasticproperties (e.g., nitinol).

In one embodiment, the suture needle disclosed herein preferably hasgreater strength than a suture needle made entirely of a highly elasticmaterial (e.g., nitinol), and the suture needle has a strength thatentirely suitable for use in suturing tissue.

When a curved suture needle having a curved elongated body is flexed(e.g., flattened) for being passed through a cannula, the maximumbending takes place at a midsection of the curved elongated body that islocated between the tissue-penetrating end and the suture attachmentend. When flexing, the greatest strain takes place along an inner radialsurface and an outer radial surface of the curved elongated body. Thecurved elongated body has a neutral axis that is near the center of theelongated body cross-section. There is no significant shear strain thatoccurs along the neutral axis, however, the degree of shear strainincreases as the distance from the neutral axis increases.

In one embodiment, a composite suture needle having a large size andconventional curvature (e.g., having a semi-circular shape) may bepassed through a lumen such as a cannula. The composite suture needle iselastically straightened as it is passed through the cannula and springsback to its original curvature upon being removed from an end of thecannula for use in surgery.

In one embodiment, the composite suture needle preferably includes anelongated body having a proximal end and a distal end with a pointedtip, and a sheath overlying the elongated body.

In one embodiment, the sheath includes a material that is more elasticthan the elongated body.

In one embodiment, the elongated body and the sheath are curved.

In one embodiment, the pointed tip extends distally beyond a distal endof the sheath.

In one embodiment, the elongated body is made of a strong alloy such asstainless steel, and sheath is made of a highly elastic material such asnitinol.

In one embodiment, the stainless steel used to make the elongated bodymay include austenitic stainless steels, martensitic-aged (mar-aged)stainless steels, and stainless steels sold under the registeredtrademark ETHALLOY Needle Alloy.

In one embodiment, the elongated body preferably has a reduced diametersection that defines a first outer diameter and the distal end of theelongated body defines a second outer diameter that is greater in sizethan the first outer diameter of the reduced diameter section.

In one embodiment, the distal end of the elongated body includes atapered section having a proximal end including a shoulder that definesthe second outer diameter. In one embodiment, the tapered sectionpreferably has a distal end that includes the pointed tip.

In one embodiment, the sheath has a proximal end, a distal end, and alumen that extends from the proximal end to the distal end of thesheath. In one embodiment, the reduced diameter section of the elongatedbody is disposed within the lumen of the sheath. In one embodiment, thelumen of the sheath has an inner diameter that is greater than or equalto the first outer diameter of the reduced diameter section of theelongated body.

In one embodiment, the sheath has an outer surface that defines a thirdouter diameter that approximates the second outer diameter of theshoulder of the tapered section of the elongated body.

In one embodiment, a composite suture needle preferably includes anelongated body having a curved proximal body section, a curved distalbody section, and a curved midsection that extends between the curvedproximal body section and the curved distal body section. In oneembodiment, the composite suture needle desirably includes a sheathoverlying the curved midsection of the elongated body. The curvedmidsection of the elongated body is desirably made of a first materialand the sheath is made of a second material that is more elastic thanthe first material of the curved midsection.

In one embodiment, the curved proximal section, the curved distalsection, and the curved midsection of the elongated body form a unitarystructure. In one embodiment, the curved proximal section, the curveddistal section, and the curved midsection of the elongated body are madeof the same material such as stainless steel.

In one embodiment, the curved midsection of the elongated body and thesheath overlying the curved midsection preferably define a flexibleregion of the composite suture needle that is more elastic than thecurved proximal body section and the curved distal body section of theelongated body of the composite suture needle.

In one embodiment, the curved midsection of the elongated body is madeof stainless steel and the sheath that overlies the curved midsection ismade of a highly elastic material such as nitinol.

In one embodiment, the sheath preferably has a proximal end, a distalend, and a lumen that extends from the proximal end to the distal end ofthe sheath. In one embodiment, the curved midsection of the elongatedbody is disposed within the lumen of the sheath.

In one embodiment, the curved midsection of the elongated body has afirst outer diameter and the lumen of the sheath has a first innerdiameter that is greater than or equal to the first outer diameter ofthe curved midsection of the elongated body.

In one embodiment, the distal end of the curved proximal section and theproximal end of the curved distal section of the elongated body define asecond outer diameter. In one embodiment, the sheath has an outersurface defining a third outer diameter that approximates the secondouter diameter.

In one embodiment, the proximal body section of the elongated bodypreferably includes a proximal end face and a suture receiving hole isformed in the proximal end face.

In one embodiment, the curved distal body section of the elongated bodyincludes a tissue piercing point at a distal end thereof.

In one embodiment, the sheath may be glued or welded to the curvedmidsection of the elongated body.

In one embodiment, a composite suture needle preferably includes acurved proximal body section made of stainless steel, a curved distalbody section made of stainless steel, and a connector interconnectingthe curved proximal and distal body sections.

In one embodiment, the connector is preferably made of a material thatis more elastic than the stainless steel used to make the curvedproximal and distal body sections.

In one embodiment, the connector interconnects a distal end of thecurved proximal body section with a proximal end of the curved distalbody section.

In one embodiment, the connector may include a dovetail structure forbeing connected with the distal end of the curved proximal body sectionand the proximal end of the curved distal body section.

In one embodiment, the connector preferably has an outer diameter thatapproximates an outer diameter of the distal end of the curved proximalbody section and an outer diameter of the proximal end of the curveddistal body section of the composite suture needle.

In one embodiment, the connector is made of nitinol and the stainlesssteel used for making the proximal and distal body sections may beaustenitic stainless steels, martensitic-aged (mar-aged) stainlesssteels, and/or stainless steels sold under the registered trademarkETHALLOY Needle Alloy.

In one embodiment, the elongated body of the composite suture needle iscurved along its length with one surface of the elongated body definingthe concave aspect of the curve and another surface of the elongatedbody defining the convex aspect of the curve.

In one embodiment, a surgical method preferably includes passing thecomposite suture needle through a lumen of a cannula from the proximalend to the distal end of the cannula, whereby during the passing stepthe composite suture needle flattens out for transforming to a heightthat is less than or equal to the height of the lumen.

In one embodiment, after the passing step, the composite suture needleis preferably removed from the distal end of the cannula whereupon thecomposite suture needle transforms back to a curved shape having aheight that is greater than the height of the lumen of the cannula.

In one embodiment, the composite suture needle may be elasticallydeformed to lower the height and/or the profile of the suture needle topass the suture needle through a cannula, such as a cannula having adiameter of 5 mm or smaller.

In one embodiment, a needle driver may be used to secure a distal end ofthe composite suture needle with the suture attachment barrel of thecomposite suture needle trailing behind the tip of the composite sutureneedle. In one embodiment, the tip is preferably surrounded by clampingjaws at the distal end of a needle driver for protecting the tip as thecomposite suture needle is passed through a cannula. The clamping jawspreferably surround and protect the tip for preventing the tip fromcontacting the inside of the cannula as it is passed through thecannula, thereby avoiding damage to the tip during its passage throughthe cannula.

In one embodiment, when the composite suture needle is held by theneedle driver, the tip of the composite suture needle does not extend orprotrude outside the external surface of the needle holder.

In the case of suture needles made of 420 alloys, forming a hole bymechanical drilling may be successfully completed using conventionalmethods because the core wire is the same as the needle wire that iscurrently being drilled.

In one embodiment, the core alloy may be chemically leached orelectropolished to a specified depth at the proximal end of the needleto produce a hole for suture needle attachment while leaving the morechemically inert nitinol outer shell intact, which may be especiallyapplicable when using high strength martensitic-aged alloys and the likeas a core material.

In one embodiment, grinding the point end and/or forming cutting edgesmay be easier since the point end is made from the core wire material,and not the super elastic material (e.g., not nitinol).

In one embodiment, curve setting may be facilitated since the core alloywill enable the needle to be curved with conventional curving equipmentused in the art of suture needle manufacture. By allowing the core alloyto plastically deform in the curving process, it provides a resistanceto the nitinol that has a propensity to straighten back to its originalform after conventional curving methods have been applied.

In one embodiment, the suture needles may be gathered in bulk andefficiently routed through a shape setting heat cycle, thus obviatingthe need for heat setting fixtures and additional handling required toshape-set monolithic nitinol alloy needles.

In one embodiment, when a needle needs to be flexed for being passedthrough a cannula, the maximum bending takes place between thetissue-penetrating end and the suture attachment end (i.e., themidsection). When flexing, the greatest strain takes place along theinner radius surface and the opposing outer radius surface.

In one embodiment, a method of making a composite suture needlepreferably includes obtaining a length of core wire made from a suitablematerial for use in the fabrication of suture needles. The core wirepreferably includes an outer diameter, a first end and a second distalend.

In one embodiment, the method preferably includes obtaining an outersheath (e.g., a sleeve, tubing) of similar or shorter length as thelength of the core wire. The sheath preferably has a proximal end and adistal end.

In one embodiment, the sheath preferably has an inner diameter that isslightly larger than the outer diameter of the core wire, and an outerdiameter approximating the desired finished outer diameter of thecomposite suture needle.

In one embodiment, a length of core wire is placed inside the sheath foraligning the proximal end of the core wire with the proximal end of thesleeve.

In one embodiment, the sheath may be fixed to the core wire using athermal shrink fit process. In one embodiment, the sheath may be heatedto thermally expand the diameter of the sheath to enable the sheath toslide over the core wire (e.g., an elongated body made of stainlesssteel). After the sheath is positioned over the core wire, the sheathmay cool to thermally contract the diameter of the sheath to hug orsnuggly fit over the core wire, thereby forming a composite sutureneedle having a flexible region that is covered by the sheath.

In one embodiment, the sheath may be affixed to the core wire byapplying an adhesive in the space between the outer diameter of the corewire and inner diameter of the sheath.

In one embodiment, the sheath may be affixed to the core wire by using alinking material between the outer diameter of the core wire and theinner diameter of the sheath, whereby the linking material is weldableto both the core wire material and the sheath material.

In one embodiment, a hole for receiving a suture may be formed in thecomposite suture needle by drilling the core material at the proximalend of the composite suture needle, or especially for high strengthmar-arged alloys, electrochemically etching/leaching the core wire to aspecified depth to produce a symmetrical suture receiving hole.

In one embodiment, the distal end of the core wire may be ground (ormaterial may be removed) from the distal end of the composite structureto form a point at the distal end of the composite suture needle.

In one embodiment, a composite suture needle may have a stainless steelcore and a connector component made of a highly elastic material that isonly present along the inner radius surface and the opposing outerradius surface of the suture needle. The mating of the highly elasticconnector component to the conventional suture needle material of thecore may be achieved in a similar manner as the sheath or sleeveconfiguration (e.g., affixing, gluing, or welding). In one embodiment,however, the highly elastic connector component may include a mechanicalattachment structure, such as a dovetail joining component.

In one embodiment, the composite suture needle may be curved withequipment and methods known in the art, to produce a free-standingcomposite suture needle having a steel core and a nitinol sheath thatmay be subsequently thermally treated to shape set the outer nitinolsleeve component without the need for fixtures or elaborate additionalprocesses.

In one embodiment, where the core material of the composite sutureneedle is a martensitic-aged alloy, the shape setting and precipitationstrengthening heat treatment steps may be conducted at the same time(e.g., at 480 degrees C. or higher for two or more minutes).

In one embodiment, a method of making a composite suture needlepreferably includes obtaining a length of core wire made from a suitablematerial for use in the fabrication of suture needles, the core wirehaving an outer diameter, a proximal end and a distal end, and forming athin strip of nitinol around the steel core wire by simultaneouslypulling the steel core wire and the nitinol strip through a series ofreducing dies suitable for the manufacture of round tubing.

In one embodiment, as the nitinol tube is formed around the steel corethrough the progression of die drawing steps, a seam of the nitinol maybe welded via laser or micro-TIG welding techniques.

In one embodiment, the elastic sheath may be shorter than the core wire.

In one embodiment, the composite suture needle may be mechanicallydrilled and/or laser drilled for forming suture receiving holes.

In one embodiment, the suture receiving hole may be chemically orelectrochemically formed by etching away the core material.

In one embodiment, the composite suture needles may be curved to aspecified free-standing shape and then heat treated in bulk to completethe shape setting process.

These and other preferred embodiments of the present patent applicationwill be described in more detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a suture needle.

FIG. 1B is a side elevation view of the suture needle shown in FIG. 1A.

FIG. 1C is a schematic view of the suture needle shown in FIGS. 1A and1B.

FIG. 1C-1 is a magnified cross-sectional view of a midsection of thesuture needle shown in FIG. 1C.

FIG. 2A is a side view of an elongated body of a composite sutureneedle, in accordance with one embodiment of the present patentapplication.

FIG. 2B is a magnified view of a distal end of the elongated body shownin FIG. 2A.

FIG. 3A is a side view of a sheath of a composite suture needle, inaccordance with one embodiment of the present patent application.

FIG. 3B is a cross-sectional view of the sheath shown in FIG. 3A.

FIG. 4A is a side view of a composite suture needle including the sheathof FIGS. 3A and 3B assembled with the elongated body of FIGS. 2A and 2B,in accordance with one embodiment of the present patent application.

FIG. 4B is a cross-sectional view of the composite suture needle shownin FIG. 4A.

FIG. 4C is another cross-sectional view of the composite suture needleof FIG. 4A.

FIG. 4D is still another cross-section view of the composite sutureneedle shown in FIG. 4A.

FIG. 5A is a perspective view of a distal section of a needle driverhaving a clamping assembly at a distal end thereof, in accordance withone embodiment of the present patent application.

FIG. 5B is a perspective view of the clamping assembly located at adistal end of the needle driver shown in FIG. 5A.

FIG. 6A shows a stage of a method of using a needle driver to advance acomposite suture needle having a highly elastic section toward a distalend of a cannula, in accordance with one embodiment of the presentpatent application.

FIG. 6B shows the needle driver and the composite suture needle of FIG.6A after the composite suture needle has been advanced beyond the distalend of the cannula for being located at a surgical site, in accordancewith one embodiment of the present patent application.

FIG. 6C shows a stage of a method of using a needle driver to retract acomposite suture needle from a surgical site and toward a proximal endof the cannula, in accordance with one embodiment of the present patentapplication.

FIG. 6D shows a later stage of a method of retracting the compositesuture needle toward the proximal end of the cannula, in accordance withone embodiment of the present patent application.

FIG. 7A is a side view of an elongated body of a composite sutureneedle, in accordance with one embodiment of the present patentapplication.

FIG. 7B is a magnified view of a distal end of the elongated body shownin FIG. 7A.

FIG. 7C is a magnified view of a proximal end of the elongated bodyshown in FIG. 7A.

FIG. 8A is a side view of a sheath of a composite suture needle, inaccordance with one embodiment of the present patent application.

FIG. 8B is a cross-sectional view of the sheath shown in FIG. 8A.

FIG. 9A is a side view of a composite suture needle including the sheathof FIGS. 8A and 8B assembled with the elongated body of FIGS. 7A-7C, inaccordance with one embodiment of the present patent application.

FIG. 9B is a cross-sectional view of the composite suture needle shownin FIG. 9A.

FIG. 10 is a side view of an elongated body of a composite sutureneedle, in accordance with one embodiment of the present patentapplication.

FIG. 11A is a side view of a sheath of a composite suture needle, inaccordance with one embodiment of the present patent application.

FIG. 11B is a cross-sectional view of the sheath shown in FIG. 11A.

FIG. 12A is a side view of a composite suture needle including thesheath of FIGS. 11A and 11B assembled with the elongated body of FIG. 10, in accordance with one embodiment of the present patent application.

FIG. 12B is a cross-sectional view of the composite suture needle shownin FIG. 12A.

FIG. 13A is a side view of a composite suture needle having an elongatedbody with a curved configuration and a highly elastic component thatinterconnects a proximal section and a distal section of the elongatedbody, in accordance with one embodiment of the present patentapplication.

FIG. 13B is a cross-sectional view of the highly elastic component ofthe composite suture needle shown in FIG. 13A, which interconnects theproximal section and the distal section of the elongated body.

FIG. 14A is a side view of a composite suture needle having a highlyelastic section located between proximal and distal ends of thecomposite suture needle, in accordance with one embodiment of thepresent patent application.

FIG. 14B is a cross-sectional view of the composite suture needle shownin FIG. 14A.

FIG. 15A is perspective view of the composite suture needle in FIG. 14Aafter it has been bent at the highly elastic section, in accordance withone embodiment of the present patent application.

FIG. 15B is a side view of the composite suture needle shown in FIG.15A.

FIG. 16 shows the composite suture needle of FIGS. 15A and 15B in a bentconfiguration for enabling the composite suture needle to be passedthrough a cannula, in accordance with one embodiment of the presentpatent application.

FIG. 17A shows a perspective view of a composite suture needle having ahighly elastic midsection for enabling the composite suture needle to bemoved into a bent configuration for being passed through a cannula, inaccordance with one embodiment of the present patent application.

FIG. 17B shows an end view of the composite suture needle shown in FIG.17A.

FIG. 17C shows a side view of the composite suture needle shown in FIGS.17A and 17B.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIGS. 1A-1C show a conventional suture needle 50 having an elongatedbody 52 with a proximal end 54 and a distal end 56. The elongated body52 of the suture needle 50 is curved and has a half circle orsemi-circular shape.

The suture needle 50 includes a suture attachment barrel 58 that isadjacent the proximal end 54 of the elongated body 52, and a sutureattachment opening 60 that is formed in a proximal face of the sutureattachment barrel. An end of a surgical suture (e.g., a filamentaryelement) is inserted into the suture attachment opening 60 and thesuture attachment barrel 58 is swaged for securing the end of thesurgical suture to the suture attachment barrel 58 of the elongated body52 of the suture needle 50.

The suture needle 50 includes a tip 62, such as a sharpened or pointedtip, that is integral to the distal end 56 of the elongated body 52 andthat defines a leading or distal-most end of the suture needle 50. Thetip 62 is sharpened for piercing tissue to facilitate passing the distalend 56 of the elongated body 52 of the suture needle 50 through tissueduring a suturing operation.

Referring to FIGS. 1B and 1C, the elongated body 52 of the suture needle50 includes an inner radial surface 64 that extends along the inside ofthe curve of the curved elongated body 52 (i.e., the concave curvedsurface), and an outer radial surface 66 that extends along the outsideof the curve of the curved elongated body 52 (i.e., the convexly curvedsurface). The inner and outer radial surfaces 64, 66 of the elongatedbody 52 define the thickness T of the elongated body 52 of the sutureneedle 50, whereby the axis for measuring the thickness T of theelongated body is perpendicular to the neutral axis A of the elongatedbody 52 of the suture needle 50.

When the suture needle 50 is in its original, half-circle configuration,the elongated body 52 of the suture needle 50 defines a height H. Whenexternal forces are exerted upon the outer surfaces of the elongatedbody 52 of the suture needle 50 (e.g., when passing the suture needlethrough the lumen of a cannula), the elongated body will flex, bend,straighten, and/or flatten out for transforming into an elongated bodyhaving a lower height or profile than the original height H.

Referring to FIGS. 1C and 1C-1 , the elongated body 52 of the sutureneedle 50 has a length L_(N) extending along the neutral axis A of theelongated body 52. The neutral axis L_(N) extends between the proximalend 54 and the distal end 56 of the elongated body 52, which is alsoreferred to as the neutral length of the suture needle 50. The elongatedbody 52 of the suture needle 50 has a top length L_(T) that extendsalong the inner radial surface 64 of the elongated body 52 between theproximal end 54 and the distal end 56 of the elongated body, and abottom length L_(B) that extends along the outer radial surface 66 ofthe elongated body 52 between the proximal end 54 and the distal end 56of the elongated body 52.

Referring to FIG. 1C-1 , when a midsection 68 of the elongated body 52of the suture needle 50 is straightened for being passed through acannula, tension and compression forces are applied at the respectiveinner and outer surfaces 64, 66 of the elongated body 52 of the sutureneedle 50. When the midsection 68 of the elongated body 52 isstraightened, the inner radial surface 64 of the elongated body 52 isunder tension, and the outer radial surface 66 of the elongated body 52is under compression. The part of the elongated body 52 that extendsalong the neutral axis A that defines the neutral length L_(N) of theelongated body 52 is under neither tension nor compression. The elasticstrain calculation associated with transforming the half circle sutureneedle (shown in FIGS. 1A-1C and 1C-1 ) to a straightened configurationmay be calculated using the equation ε=ΔL/L_(N), where ΔL is the changein the top length L_(T) of the suture needle at the inner radial surface64 of the elongated body 52 or the change in the bottom length L_(B) ofthe suture needle at the outer radial surface 66 of the elongated body52, and L_(N) is the neutral length of the elongated body of the sutureneedle that is mid-way between the inner and outer radial surfaces 64,66 of the elongated body.

When the suture needle 50 is flexed for being passed through the lumenof a cannula, the maximum bending takes place at the midsection 68 ofthe elongated body 52. When flexing, the greatest strain takes placealong the inner radial surface 64 and the outer radial surface 66 of theelongated body 52. The neutral axis A that extends along the neutrallength L_(N) is near the center of the cross-section of the elongatedbody. During flexing (e.g., straightening) of the elongated body, thereis no shear strain that occurs along the neutral axis A that extendsalong the neutral length L_(N) of the elongated body 52. The degree ofstrain increases, however, as the distance from the neutral axis L_(N)increases. Thus, during flexing of the suture needle 50, the shearstrain is greater at the inner and outer radial surfaces 64, 66 andlower or negligible along the neutral length L_(N).

In one embodiment, a composite suture needle preferably includes a corecomponent made of a first material and a second component made of asecond material that is more elastic than the first material. In oneembodiment, the first component may include a core component made ofstainless steel, and the second component may include an outer sheathmade of a highly elastic material (e.g., nitinol) that covers a sectionof the core component.

Referring to FIGS. 2A and 2B, in one embodiment, a composite sutureneedle 100 preferably includes an elongated body 102 (i.e., the corecomponent) having a proximal end 104 and a distal end 106. In oneembodiment, the distal end 106 of the elongated body 102 preferablyincludes a tapered section 108 having a proximal end 110 that defines ashoulder 112 and a distal end 114 that includes a sharpened or pointedtip 116. The tapered section 108 preferably tapers inwardly between theproximal end 110 and the distal end 114 thereof. In one embodiment, thepointed tip 116 at the distal end 114 of the tapered section 108preferably defines a leading end of the elongated body 102, which isdesigned for piercing tissue to facilitate passing the distal end 106 ofthe elongated body 102 through tissue during a suturing operation.

In one embodiment, the elongated body 102 of the composite suture needle100 preferably includes a reduced diameter section 118 that extendsbetween the proximal end 104 of the elongated body and the largerdiameter shoulder 112 of the tapered section 108. In one embodiment, thereduced diameter section 118 has a cross-section having a circularshape, which is configured to receive a sheath made of a highly elasticmaterial, as will be described in more detail herein.

Referring to FIG. 2B, in one embodiment, the reduced diameter section118 of the elongated body 102 preferably defines a first outer diameterOD₁ and the shoulder 112 of the tapered section 108 preferably defines asecond outer diameter OD₂ that is greater than the first outer diameterOD₁ of the reduced diameter section 118 of the elongated body 102.

Referring to FIGS. 2A and 2B, in one embodiment, the elongated body 102may be curved and/or may have a half circle or semi-circular shape. Inone embodiment, the reduced diameter section 118 of the elongated body102 is curved and preferably includes a concave surface 120 that extendsalong the inside of the curve of the reduced diameter section and aconvexly curved outer surface 122 that extends along the outside of thecurve of the reduced diameter section 118. The elongated body 102preferably defines a first height H₁.

In one embodiment, the elongated body 102 may be made of strong alloyssuch as stainless steels. In one embodiment, the stainless steels mayinclude austenitic stainless steels (302SS), and martensitic-aged(mar-aged) stainless steels (455SS).

The austenitic stainless steels (302SS) may possess austenite as theirprimary crystalline structure. The austenite crystalline structure isachieved by sufficient additions of the austenite stabilizing elementsnickel, manganese and nitrogen. Due to their crystalline structureaustenitic steels are not hardenable by heat treatment. Seehttps://en.wikipedia.org/wiki/Austenitic_stainless_steel. Nevertheless,exceptionally high strength may be achieved via work hardeningespecially in the wire drawing process used to produce feedstock forneedle manufacturing.

The martensitic-aged (mar-aged) stainless steels (455SS) are preferablysteels that are known for possessing superior strength and toughnesswithout losing malleability. The “aging” portion of the word Mar-agedrefers to the extended heat-treatment process. These steels are aspecial class of low-carbon, ultra-high-strength steels that derivetheir strength not from carbon, but from precipitation of intermetalliccompounds. Typically, the principal alloying element is 7 to 25 wt. %nickel. Secondary alloying elements, which include titanium and copper,are added to produce intermetallic precipitates. Seehttps://www.asminternational.org/c/portal/pdf/download?articleId=AMP16909P30&groupId=10192

One type of martensitic-aged alloy that was specifically developed forsuture needles and that provides levels of strength far exceeding thatof alloys previously used for making suture needles is sold under theregistered trademark ETHALLOY Needle Alloy. The ETHALLOY Needle Alloy isstrengthened by a combination of work hardening and thermal processing(precipitation strengthening).

Referring to FIGS. 3A and 3B, in one embodiment, a composite sutureneedle 100 preferably includes a sheath 124 made of a material havinghigher level of elasticity than the material used to make the elongatedbody 102 (FIGS. 2A and 2B) of the composite suture needle. In oneembodiment, the sheath 124 may be made of a highly elastic material suchas nitinol. In one embodiment, the sheath 124 may have a sleeve,tubular, or cylindrical shape. In one embodiment, the sheath 124 ispreferably sized, shaped and/or configured to be assembled over thereduced diameter section 118 of the elongated body 102 (FIGS. 2A and 2B)to form the composite suture needle 100 including the elongated body,which is relatively less elastic, and the sheath 124, which isrelatively more elastic than the material used to make the elongatedbody.

In one embodiment, the sheath 124 preferably has a proximal end 126, adistal end 128, and a lumen 130 that extends from the proximal end 132to the distal end 134 thereof. Referring to FIGS. 2B and 3B, in oneembodiment, the lumen 136 of the sheath 124 desirably defines an innerdiameter ID₁ that is slightly larger than the outer diameter OD₁ of thereduced diameter section 118 of the elongated body 102. In oneembodiment, the sheath 124 has an outer surface 132 that preferablydefines an outer diameter OD₃ that approximates the outer diameter OD₂of the shoulder 112 of the tapered section 108 of the elongated body102. In one embodiment, when the sheath 124 is assembled over thereduced diameter section 118 of the elongated body to form a compositeneedle 100, the distal end 128 of the sheath 124 preferably abutsagainst the shoulder 112 of the tapered section 108 of the elongatedbody 102. In one embodiment, the outer surface 132 of the sheath 124approximates the outer surface at the proximal end 110 of the taperedsection 108 of the elongated body to provide a smooth transition betweenthe tapered section 108 and the sheath 124 of the composite sutureneedle.

In one embodiment, the sheath desirably covers most of the length of theelongated body. In one embodiment, the proximal end of the sheathpreferably extends proximally beyond the proximal end of the elongatedbody to provide a suture receiving hole. In one embodiment, the sheathmay be slid over the elongated body to form a thermal fit and/or acompression fit between the sheath and the elongated body.

Referring to FIGS. 4A and 4B, in one embodiment, the composite sutureneedle 100 may be formed by assembling the sheath 124 over the reduceddiameter section 118 of the elongated body 102. In one embodiment, thedistal end 128 of the sheath 124 preferably abuts against the shoulder112 (FIG. 2B) of the tapered section 108 of the elongated body 102. Theinner diameter ID₁ of the sheath 124 is preferably slightly larger thanthe outer diameter OD₁ (FIG. 2B) of the reduced diameter section 118 ofthe elongated body 102. The outer surface 132 of the sheath 124preferably defines an outer diameter OD₃ (FIG. 3B) that approximates theouter diameter at the proximal end 110 of the tapered section 108 of theelongated body 102.

In one embodiment, after the sheath 124 has been assembled over thereduced diameter section 118 of the elongated body 102, the proximal end126 of the sheath 124 preferably extends proximally beyond the proximalend 104 of the elongated body 102 to define a suture attachment opening134 that is located at the proximal end of the composite suture needle100. The suture attachment opening 134 is preferably surrounded by aswage zone 136 of the sheath 124 that may be swaged or crimped forsecuring an end of a suture thread to the proximal end of the compositesuture needle 100. In one embodiment, an end of a suture thread (notshown) may be inserted into the suture attachment opening 134 of thesheath 124 and the swage zone 136 of the sheath 124 may be swaged forsecuring the end of the suture thread to the proximal end of thecomposite suture needle 100.

Referring to FIGS. 4B-4D, in one embodiment, the sheath 124 may beaffixed to the reduced diameter section 118 of the elongated body 102 byapplying heat to the sheath to cause the inner diameter ID₁ of thesheath to shrink in size so as to hug or snuggly fit the outer surfaceof the reduced diameter section 118, thereby forming the compositesuture needle 100 having a more elastic section. In one embodiment, themore elastic section of the composite suture needle is preferably thesection of the composite suture needle where the sheath 124 extends overthe reduced diameter section 118.

In one embodiment, the sheath 124 may be affixed to the reduced diametersection 118 of the elongated body 102 by applying an adhesive within aspace 138 that is located between an outer surface of the reduceddiameter section 118 and an inner surface of the sheath 124.

In one embodiment, the sheath 124 may be affixed to the reduced diametersection 118 of the elongated body 102 by using a linking materialdisposed within the space 138 that is located between the outer surfaceof the reduced diameter section 118 and the inner surface of the sheath124, whereby the linking material is preferably weldable to both thematerial used to make the elongated body 102 (e.g., stainless steel) andthe material used to make the sheath 124 (e.g., nitinol).

In one embodiment, the composite suture needle 100 preferably includesthe reduced diameter section 118 and the sheath 124 that overlies thereduced diameter section. The length of the elongated body 118 that iscovered by the sheath 124 preferably defines a more elastic region ofcomposite suture needle 100, which is designed to flex (e.g., flatten)when being passed through a smaller cannula without being plasticallydeformed. Due to the presence of the more elastic region formed by thecombination of the reduced diameter section 118 and the highly elasticsheath 124, after the composite suture needle 100 is removed from an endof the cannula (e.g., at a surgical site), the elongated body 102 of thecomposite suture needle 100 will preferably return (e.g., spring back)to its normal, semi-circular shaped configuration so that the compositesuture needle 100 may be used for suturing tissue.

In one embodiment, the composite suture needle disclosed herein isdesigned to exhibit elasticity for passing through a smaller cannula(e.g., a 5 mm cannula) without substantial plastic deformation. In oneembodiment, the elongated body of the composite suture needle (i.e., theelongated body 102 shown in FIG. 2A) is made of stainless steel such ashigh strength stainless steel. In one embodiment, knowing the yieldstrength and the Young's modulus for the stainless steel used to makethe elongated body of the composite suture needle, the elongated bodymay be designed with the reduced diameter section having diameterdimensions that will make the composite suture needle elasticallydeformable without being plastically deformed.

The yield point for a material is the point on a stress-strain curvethat indicates the limit of elastic behavior for the material and thebeginning of plastic behavior. Yield strength or yield stress is thematerial property defined as the stress at which a material begins todeform plastically whereas yield point is the point where nonlinear(elastic+plastic) deformation begins. Prior to the yield point thematerial will deform elastically and will return to its original shapewhen the applied stress is removed. Once the yield point is passed,however, some fraction of the deformation will be permanent andnon-reversible. The yield point determines the limits of performance formechanical components, since it represents the upper limit to forcesthat can be applied without permanent deformation.

The Young's modulus of a material is one way to measure the modulus ofelasticity of a material. A modulus of elasticity is a quantity thatmeasures an object's resistance to being deformed elastically (i.e.,non-permanently) when a stress is applied to it. The modulus ofelasticity of an object is defined as the slope of its stress-straincurve in the elastic deformation region. A stiffer material will have ahigher modulus of elasticity.

Specifying how stress and strain are to be measured, includingdirections, allows for many types of elastic moduli to be defined.Young's modulus (E) describes tensile elasticity, or the tendency of anobject to deform along an axis when opposing forces are applied alongthat axis. It is defined as the ratio of tensile stress to tensilestrain. It is often referred to simply as the elastic modulus.

In one embodiment, the elongated body of the composite suture needle ispreferably elastically deformable from a half-circle shape to a flattershape having a straightened section without plastically deforming theelongated body of the composite suture needle. As a result, when theelastic suture needle is passed through a smaller cannula and isextracted at a surgical site, the elongated body of the composite sutureneedle will preferably spring back to its original half circle shape.

As is known to those skilled in the art, most materials can withstand amodest degree of strain before becoming plastically deformed. In oneembodiment, the sheath 124 is preferably made of a highly elasticmaterial (e.g., nitinol) that will withstand more strain, as compared toless elastic materials (e.g., stainless steel) before becomingplastically deformed. In one embodiment, the composite suture needle 100includes a highly elastic material at the greatest distances from theneutral axis L_(N) (FIG. 4D), which will be able to withstand moreflexing before becoming plastically deformed as compared to aconventional suture needle made from a single, less elastic material(e.g., stainless steel) having uniform elastic properties. This isbecause the outer diameter OD₁ of the reduced diameter section 118 ofthe elongated body 102 is smaller than the outer diameter OD₃ of thecomposite suture needle 100.

Referring to FIGS. 5A and 5B, in one embodiment, a clamping element suchas a needle driver 150 may be utilized for securing a composite sutureneedle, such as the composite suture needle 100 shown and describedabove in FIGS. 2A-2B, 3A-3B, and 4A-4D, to remove the composite sutureneedle from a suture needle package and/or to advance the compositesuture needle through the lumen of a cannula to position the compositesuture needle at a surgical site for performing a suturing operation. Inone embodiment, the shape of the elongated body of the composite sutureneedle may change (e.g., flatten) as the needle driver 150 advances thecomposite suture needle through the cannula. In one embodiment, thecomposite suture needle may have a semi-circular shape that defines afirst height H₁ (FIG. 4A) and a more elastic midsection that enables thecomposite suture needle to flex from the half circle shape to a flattershape. As the needle driver 150 advances the composite suture needlethrough a cannula having an inner diameter that is smaller than thefirst height H₁ of the composite suture needle 100 (FIG. 4A), the innerwalls of the cannula may apply external forces upon the elongated bodyof the composite suture needle whereupon the elongated body of thecomposite suture needle will flatten out or become straighter along thereduced diameter section 118 (FIG. 4B) of the elongated body of thecomposite suture needle for transforming to a smaller, second height forfitting through the smaller inner diameter of the cannula. Upon beingextracted from the end of the cannula, the inner walls of the cannula nolonger apply the external forces upon the composite suture needle,whereupon the elongated body of the composite suture needle willpreferably transform back (e.g., spring back) to its original halfcircle shape having the first height H₁ (FIG. 4A).

In one embodiment, the needle driver 150 preferably includes anelongated shaft 152 having a proximal end 154 and a distal end 156 witha clamping assembly 158 that is movable between open and closedpositions. In one embodiment, the clamping assembly 158 preferablyincludes a lower jaw 160 and an opposing upper jaw 162 that is movablebetween open and closed positions. In one embodiment, with the clampingassembly 158 in the open position, the lower and upper jaws 160, 162 maybe guided into alignment with the tip 116 of the composite suture needle100 (FIG. 2A). In one embodiment, after the lower and upper jaws arealigned with the tip of the composite suture needle, the jaws may bemoved to the closed position for clamping and/or gripping the taperedsection 108 (FIG. 2A) of the elongated body 102 of the composite sutureneedle with the tip 116 preferably positioned between and surrounded bythe opposing lower and upper jaws.

Referring to FIG. 5B, in one embodiment, the lower jaw 160 may bestationary, rigidly secured, and/or integral to the distal end 156 ofthe elongated shaft 152 of the needle driver 150 so that the lower jaw160 is fixed and does not move relative to the distal end 158 of theelongated shaft 152 of the needle driver 150. In one embodiment, thelower jaw 160 preferably includes a substantially flat top surface 164that is adapted to be aligned with the tip 116 (FIG. 2A) of thecomposite suture needle. In one embodiment, the substantially flat topsurface 164 of the lower jaw 160 may include a surface roughening suchas knurling for enhancing gripping of the distal end of the compositesuture needle when the clamping assembly 158 is in the closed position.

In one embodiment, the upper jaw 162 of the clamping assembly 158 isdesirably pivotally secured to the distal end 156 of the elongated shaft152 of the needle driver 150 via a pivot 166, which pivotally secures aproximal end of the upper jaw 162 to the distal end 156 of the elongatedshaft 152. The upper jaw 162 preferably includes a substantially flatbottom surface 168 that opposes the substantially flat top surface 164of the lower jaw 160. The substantially flat bottom surface 168 of theupper jaw 162 may include a surface roughening such as knurling forgripping the distal end of the composite suture needle when the clampingassembly 158 is in the closed position.

Referring to FIGS. 5A and 5B, in one embodiment, when the lower andupper jaws 160, 162 are in the closed position for clamping, grippingand/or securing the tapered section 108 of the elongated body 102 of thecomposite suture needle 100, the top surface 164 of the lower jaw 160engages a surface of the tapered section 108 at the distal end 106 ofthe elongated body 102 composite suture needle 100, and the bottomsurface 168 of the upper jaw 162 preferably engages another surface ofthe tapered section 108 of the elongated body 102 at the distal end 106of the composite suture needle 100, with the tip 116 of the compositesuture needle being located between the opposing jaws. In oneembodiment, when the jaws are closed, the top and bottom surfaces 164,168 of the respective lower and upper jaws 160, 162 may be spaced awayfrom the tip 116 so that the tip is not marred, bent, damaged, or dulledby the jaws of the clamping assembly. In one embodiment, the closed jaws160, 162 preferably surround the outer perimeter of the tip 116 as thecomposite suture needle 100 is passed through a cannula for preventingthe tip from scratching or being damaged by an inner wall of a cannula.

In one embodiment, a suture needle package may hold one or morecomposite suture needles, such as the composite suture needle 100 shownin FIGS. 4A-4D, so that the tip 116 of the suture needle 100 ispre-positioned at a location that will facilitate aligning the tip 116between the top and bottom surfaces 164, 168 of the respective lower andupper jaws 160, 162 of the clamping assembly 158 of the needle driver150.

Referring to FIG. 6A, in one embodiment, after the clamping assembly 158of the needle driver 150 has been closed for clamping onto the distalend 106 of the elongated body 102 of the composite suture needle 100,the needle driver 150 may be utilized for advancing the suture needle100 through a cannula 170 to position the suture needle at a surgicalsite for performing a suturing operation. In one embodiment, the cannula170 preferably has an elongated conduit 172 having an inner diameterthat defines a second height H₂ that is less than the first height H₁(FIG. 4A) of the composite suture needle. The elongated conduit 172preferably extends to an opening 174 at a distal end 176 of the cannula170. The clamping assembly 158 of the needle driver 150, clamped ontothe distal end 106 of the elongated body 102 of the composite sutureneedle 100, may be advanced toward the distal end of the conduit 172 ofthe cannula 170 for pulling the composite suture needle 100 through thecannula. As the composite suture needle 100 is pulled by the clampingassembly 158 of the needle driver 150 toward the distal end 176 of thecannula 170, the composite suture needle 100 is required to fit throughthe smaller conduit 172 having the second height H₂ that is less thanthe original, first height H₁ (FIG. 4A) of the composite suture needle100. Because the composite suture needle 100 is capable of elasticallydeforming at a midsection 125, the elongated body 102 of the compositesuture needle 100 preferably elastically deforms (e.g., straightens out,becomes flatter) as shown in FIG. 6A.

In FIG. 6A, the more elastic midsection 125 of the composite sutureneedle 100, which includes the highly elastic sheath 124 (FIGS. 4A-4D)of the composite suture needle 100 preferably straightens or flattensfor reducing the overall height of the composite suture needle to athird height H₃ that is less than the second height H₂ of the conduit172 of the cannula 170. At the smaller third height H₃, the flattenedsuture needle 100 may be passed through the smaller lumen 172 of thecannula 170. As will be described in more detail herein, the compositesuture needle is designed to be substantially elastically deformed as itpasses through the smaller cannula, changing from the first height H₁(FIG. 4A) to the third height H₃.

Referring to FIG. 6B, after the composite suture needle 100 has beenremoved from the opening 174 at the distal end 176 of the cannula 170,the composite suture needle 100 will preferably spring back to theoriginal curved configuration (e.g., a half circle shape) having thefourth height H₄ that is greater than the second height H₂ (FIG. 6A) ofthe conduit 172 of the cannula 170. Surgical personnel may utilize thecomposite suture needle 100, in the half circle shape shown in FIG. 6B,for performing a suturing operation at the surgical site.

In one embodiment, after being removed from the distal end 174 of thecannula 170, the composite suture needle 100 preferably springs back tothe fourth height H₄ that substantially matches the original, firstheight H₁ (FIG. 4A) of the composite suture needle. In one embodiment,the fourth height H₄ is about 90% of the original, first height H₁. Inone embodiment, the fourth height H₄ is about 95% of the original, firstheight H₁. In one embodiment, the fourth height H₁ substantially matchesthe original, first height H₁.

Referring to FIG. 6C, in one embodiment, at the conclusion of a suturingoperation, the curved composite suture needle 100 having the fourthheight H₄ may be removed from a patient by retracting the compositesuture needle through the cannula 170. In one embodiment, the clampingassembly 158 of the needle driver 150 is again closed for securing thetapered section 108 of the elongated body 102 of the curved compositesuture needle 100 between the lower jaw 160 and the upper jaw 162 of theneedle driver 150.

Referring to FIG. 6D, in one embodiment, at the completion of a suturingoperation, the needle driver 150 preferably retracts the compositesuture needle 100 through the conduit 172 of the cannula 170. Becausethe second height H₂ of the conduit of the cannula is smaller than thefourth height H₄ (FIG. 6B) of the composite suture needle 100, themidsection 125 of the composite suture needle 100 preferably straightensor flattens out to the third height H₃ so that the suture needle may beextracted through the conduit 172 of the cannula 170. As the compositesuture needle 100 is withdrawn through the cannula 170, the lower andupper jaws 160, 162 of the needle driver 150 preferably engage thetapered section 108 of the elongated body 102 of the composite sutureneedle 100 and surround the tip 116 (FIG. 4A) of the suture needle toprotect the tip from being damaged as the needle is pulled and/orretracted through the cannula 170.

Referring to FIGS. 7A-7C, in one embodiment, a composite suture needle200 preferably includes an elongated body 202 (i.e., the core component)having a proximal end 204 and a distal end 206. In one embodiment, thedistal end 206 of the elongated body 202 preferably includes a taperedsection 208 having a proximal end 210 that defines a distal shoulder 212and a distal end 214 that includes a sharpened or pointed tip 216. Thetapered section 208 preferably tapers inwardly between the proximal end210 and the distal end 214 thereof. In one embodiment, the pointed tip216 at the distal end 214 of the tapered section 208 preferably definesa leading end of the elongated body 202, which is designed for piercingtissue to facilitate passing the distal end 206 of the elongated body202 through tissue during a suturing operation.

In one embodiment, the proximal end 204 of the elongated body includes alarger diameter section having a proximal end 205 adapted to have asuture attached hole 207 formed therein and a distal end 209 thatdefines a shoulder 211.

In one embodiment, the elongated body 202 of the composite suture needle200 preferably includes a reduced diameter section 218 that extendsbetween the shoulder 211 at the proximal end 204 of the elongated bodyand the shoulder 212 at the distal end of the elongated body. In oneembodiment, the reduced diameter section 218 has a cross-section havinga circular shape, which is configured to receive a sheath made of ahighly elastic material, as will be described in more detail herein.

In one embodiment, the reduced diameter section 218 of the elongatedbody 202 preferably defines an outer diameter OD₄, the shoulder 211 atthe proximal end of the elongated body defines an outer diameter OD₅,and the shoulder 212 at the distal end of the elongated body alsodefines an outer diameter OD₅, whereby the outer diameters OD₅ of therespective shoulders 211, 212 are greater than the outer diameter OD₄ ofthe reduced diameter section 218 of the elongated body 202 that extendsbetween the shoulders.

In one embodiment, the elongated body 202 may be curved and/or may havea half circle or semi-circular shape. In one embodiment, the reduceddiameter section 218 of the elongated body 202 is curved and preferablyincludes a concave surface 220 that extends along the inside of thecurve of the reduced diameter section and a convexly curved outersurface 222 that extends along the outside of the curve of the reduceddiameter section 218.

In one embodiment, the elongated body 202 may be made of strong alloyssuch as stainless steels. In one embodiment, the stainless steels mayinclude austenitic stainless steels (302SS), and martensitic-aged(mar-aged) stainless steels (455SS).

Referring to FIGS. 8A and 8B, in one embodiment, the composite sutureneedle 200 preferably includes a sheath 224 made of a material havinghigher level of elasticity than the material used to make the elongatedbody 202 (FIGS. 7A-7C). In one embodiment, the sheath 224 may be made ofa highly elastic material such as nitinol. In one embodiment, the sheath224 may have a sleeve, tubular, or cylindrical shape. In one embodiment,the sheath 224 is preferably sized, shaped and/or configured to beassembled over the reduced diameter section 218 of the elongated body102 (FIGS. 7A-7C) to form the composite suture needle 200 including theelongated body, which is relatively less elastic, and the sheath 224,which is relatively more elastic than the material used to make theelongated body.

In one embodiment, the sheath 224 preferably has a proximal end 226, adistal end 228, and a lumen 230 that extends from the proximal end 232to the distal end 234 thereof. Referring to FIGS. 7A-7C and 8B, in oneembodiment, the lumen 236 of the sheath 224 desirably defines an innerdiameter ID₂ that is slightly larger than the outer diameter OD₄ of thereduced diameter section 218 of the elongated body 202. In oneembodiment, the sheath 224 has an outer surface 232 that preferablydefines an outer diameter OD₆ that approximates the outer diameters OD₅of the respective shoulders 211, 212 of the elongated body 202. In oneembodiment, when the sheath 224 is assembled over the reduced diametersection 218 of the elongated body to form a composite suture needle 200,the distal end 228 of the sheath 224 preferably abuts against theshoulder 212 at the distal end of the elongated body and the proximalend 226 of the sheath 224 preferably abuts against the shoulder 211 atthe proximal end of the elongated body. In one embodiment, the outersurface 232 at the distal end 228 of the sheath 224 approximates theouter surface at the proximal end 210 of the tapered section 208 toprovide a smooth transition between the tapered section 208 and thesheath 224 of the composite suture needle, and the outer surface 232 atthe proximal end 226 of the sheath 224 approximates the outer surface atthe distal end 209 of the proximal end 204 of the elongated body 202 toprovide for a smooth transition between the proximal end of the sheathand larger diameter section at the proximal end of the elongated body.

In one embodiment, when the sheath is assembled with the elongated bodyto form a composite suture needle, the sheath preferably traverses themajority of the length of the elongated body.

Referring to FIGS. 9A and 9B, in one embodiment, the composite sutureneedle 200 may be formed by assembling the sheath 224 over the reduceddiameter section 218 of the elongated body 202. In one embodiment, thedistal end 228 of the sheath 224 preferably abuts against the shoulder212 (FIG. 8B) at the distal end of the elongated body 202 and theproximal end 226 of the sheath 224 abuts against the shoulder 211 at theproximal end of the elongated body 202. The inner diameter ID₂ (FIG. 8B)of the sheath 224 is preferably slightly larger than the outer diameterOD₄ (FIGS. 7B and 7C) of the reduced diameter section 218 of theelongated body 202. The outer surface 232 of the sheath 224 preferablydefines an outer diameter OD₆ (FIG. 8B) that approximates the outerdiameter OD₅ (FIG. 7B) at the proximal end 210 of the tapered section208 of the elongated body 202 and the outer diameter OD₅ (FIG. 7C) atthe distal end 209 of the proximal end 204 of the elongated body 202.

In one embodiment, after the sheath 224 has been assembled over thereduced diameter section 218 of the elongated body 202, the proximal end226 of the sheath 224 preferably abuts against the shoulder 211 at theproximal end of the elongated body and the distal end 228 of the sheath224 preferably abuts against the shoulder 212 at the distal end of theelongated body 202. In one embodiment, the suture receiving hole 207 isformed in the proximal end 204 of the elongated body 202 for attachingan end of a suture thread to the proximal end of the composite sutureneedle.

Referring to FIG. 9B, in one embodiment, the sheath 224 may be affixedto the reduced diameter section 218 of the elongated body 202 byapplying heat to the sheath to cause the inner diameter of the sheath toshrink in size so as to hug or snuggly fit the outer surface of thereduced diameter section 218, thereby forming the composite sutureneedle 200 having a more elastic section. In one embodiment, the sheath224 may be affixed to the reduced diameter section 218 of the elongatedbody 202 by applying an adhesive within a space 238 that is locatedbetween an outer surface of the reduced diameter section 218 and aninner surface of the sheath 224.

In one embodiment, the sheath 224 may be affixed to the reduced diametersection 218 of the elongated body 202 by using a linking materialdisposed within the space 238 that is located between the outer surfaceof the reduced diameter section 218 and the inner surface of the sheath224, whereby the linking material is preferably weldable to both thematerial used to make the elongated body 202 (e.g., stainless steel) andthe material used to make the sheath 224 (e.g., nitinol).

In one embodiment, the composite suture needle 200 preferably includesthe reduced diameter section 218 and the sheath 224 that overlies thereduced diameter section. The length of the elongated body 202 that iscovered by the sheath 224 preferably defines a more elastic region ofthe composite suture needle 200, which is designed to flex (e.g.,flatten) when being passed through a smaller cannula without beingplastically deformed. Due to the presence of the more elastic regionformed by the combination of the reduced diameter section 218 and thehighly elastic sheath 224, after the composite suture needle 200 isremoved from an end of the cannula (e.g., at a surgical site), theelongated body 202 of the composite suture needle 200 will preferablyreturn (e.g., spring back) to its normal, semi-circular shapedconfiguration so that the composite suture needle 200 may be used forsuturing tissue.

Referring to FIG. 10 , in one embodiment, a composite suture needle 300preferably includes an elongated body 302 (i.e., the core component)having a proximal end 304 and a distal end 306 having a tapered section308 that terminates at a sharpened or pointed tip 316. The taperedsection 308 preferably tapers inwardly to the sharpened tip 316. Thesharpened tip 316 desirably defines a leading end of the elongated body302 that is adapted to pierce tissue during a suturing operation.

In one embodiment, the elongated body 302 preferably defines an outerdiameter OD₇. In one embodiment, the elongated body 302 may be curvedand/or may have a half circle or semi-circular shape. In one embodiment,the elongated body 302 is curved and preferably includes a concavesurface 320 that extends along the inside of the curve of the elongatedbody and a convexly curved outer surface 322 that extends along theoutside of the curve of the elongated body.

In one embodiment, the elongated body 302 may be made of strong alloyssuch as stainless steels. In one embodiment, the stainless steels mayinclude austenitic stainless steels (302SS), and martensitic-aged(mar-aged) stainless steels (455SS).

Referring to FIGS. 11A and 11B, in one embodiment, the composite sutureneedle 300 preferably includes a sheath 324 made of a material havinghigher level of elasticity than the material used to make the elongatedbody 302 (FIG. 10 ) of the composite suture needle. In one embodiment,the sheath 324 may be made of a highly elastic material such as nitinol.In one embodiment, the sheath 324 may have a sleeve, tubular, orcylindrical shape. In one embodiment, the sheath 324 is preferablysized, shaped and/or configured to be assembled over the elongated body302 (FIG. 10 ) to form the composite suture needle 300 including theelongated body, which is relatively less elastic, and the sheath 324,which is relatively more elastic than the material used to make theelongated body.

In one embodiment, the sheath 324 preferably has a proximal end 326, adistal end 328 with a tapered outer surface 335, and a lumen 330 thatextends from the proximal end 326 to the distal end 328 thereof.Referring to FIGS. 10 and 11A-11B, in one embodiment, the lumen 330 ofthe sheath 324 desirably defines an inner diameter ID₃ that is slightlylarger than the outer diameter OD₇ (FIG. 10 ) of the elongated body 302.In one embodiment, when the sheath 324 is assembled over the elongatedbody 302 to form a composite suture needle 300, the tapered outersurface 335 at the distal end 328 of the sheath 324 preferablyapproximates with the outer surface of the tapered section 308 at thedistal end 306 of the elongated body 302 to provide a smooth transitionbetween the distal end 328 of the sheath 324 and the tapered section 308of the elongated body 302.

In one embodiment, when the sheath is assembled with the elongated bodyto form a composite suture needle, the sheath preferably covers themajority of the length of the composite suture needle. In oneembodiment, the sheath may be formed around the elongated body andpresented to needle making equipment as a pre-made composite wire. Theneedle making equipment may be used to grind a tip to expose thestainless steel of the elongated body. The proximal end of the elongatedbody may be drilled, laser drilled, and/or electropolished to produce asuture receiving hole.

Referring to FIGS. 12A and 12B, in one embodiment, the composite sutureneedle 300 may be formed by assembling the sheath 324 over the elongatedbody 302 (FIG. 10 ). In one embodiment, the tapered section 335 at thedistal end 328 of the sheath 324 preferably overlies the tapered section308 at the distal end 306 of the elongated body 302. The inner diameterID₃ (FIG. 11B) of the sheath 324 is preferably slightly larger than theouter diameter OD₇ (FIG. 10 ) of the elongated body 302.

In one embodiment, after the sheath 324 has been assembled over theelongated body 302, the sharpened tip 316 and a distal portion of thetapered section 308 of the elongated body 302 preferably projects beyondthe tapered section 335 at the distal end 328 of the sheath 324.

Referring to FIG. 12B, in one embodiment, the sheath 324 may be affixedto the elongated body 302 by applying heat to the sheath to cause theinner diameter of the sheath to shrink in size so as to hug or snugglyfit the outer surface of the elongated body 302, thereby forming thecomposite suture needle 300 having an elastic section. In oneembodiment, the sheath 324 may be affixed to the elongated body 302 byapplying an adhesive within a space 338 that is located between an outersurface of the elongated body 302 and an inner surface of the sheath324.

In one embodiment, the sheath 324 may be affixed to the elongated body302 by using a linking material disposed within the space 338 that islocated between the outer surface of the elongated body 302 and theinner surface of the sheath 324, whereby the linking material ispreferably weldable to both the material used to make the elongated body302 (e.g., stainless steel) and the material used to make the sheath 324(e.g., nitinol).

In one embodiment, the composite suture needle 300 preferably includesthe elongated body 302 and the sheath 224 that overlies the elongatedbody. The length of the elongated body 302 that is covered by the sheath324 preferably defines a more elastic region of composite suture needle300, which is designed to flex (e.g., flatten) when being passed througha smaller cannula without being plastically deformed. Due to thepresence of the more elastic region formed by the combination of theelongated body 302 and the highly elastic sheath 324, after thecomposite suture needle 300 is removed from an end of the cannula (e.g.,at a surgical site), the elongated body 302 of the composite sutureneedle 300 will preferably return (e.g., spring back) to its normal,semi-circular shaped configuration so that the composite suture needle300 may be used for suturing tissue.

In one embodiment, after the sheath 324 has been assembled over theelongated body 302, the proximal end 326 of the sheath 324 preferablyextends proximally beyond the proximal end 304 of the elongated body 302to define a suture attachment opening 334 that is located at theproximal end of the composite suture needle 300. The suture attachmentopening 334 is preferably surrounded by a swage zone 336 of the sheath324 that may be swaged or crimped for securing an end of a suture threadto the proximal end of the composite suture needle 300. In oneembodiment, an end of a suture thread (not shown) may be inserted intothe suture attachment opening 334 of the sheath 324, and the swage zone336 of the sheath 324 may be swaged for securing the end of the suturethread to the proximal end of the composite suture needle 300.

Referring to FIG. 13A, in one embodiment, a composite suture needle 400having a highly elastic midsection 425 preferably includes an elongatedbody 402 with a proximal end 404 and a distal end 406. The elongatedbody 402 of the composite suture needle 400 may be curved and may have ahalf circle or semi-circular shape.

In one embodiment, the highly elastic midsection 425 is configured to bea highly elastic region of the composite suture needle 400 for enablingthe composite suture needle to be straightened for being passed througha smaller cannula, and then returned back to its original curvedconfiguration for being used in a suturing operation.

In one embodiment, the composite suture needle 400 desirably includes asuture attachment barrel 408 that is adjacent the proximal end 404 ofthe elongated body 402, and a suture attachment opening 410 that isformed in a proximal face of the suture attachment barrel 408. An end ofa surgical suture (e.g., a filamentary element; a thread) may beinserted into the suture attachment opening 410 and the sutureattachment barrel 408 may be swaged for securing the end of the surgicalsuture to the proximal end 404 of the elongated body 402 of thecomposite suture needle 400.

In one embodiment, the composite suture needle 400 preferably includes atip 412, such as a sharpened or pointed tip, that is integral to thedistal end 406 of the elongated body 402 and that desirably defines aleading or distal-most end of the composite suture needle 400. The tip412 is preferably sharpened for piercing tissue to facilitate passingthe distal end 406 of the elongated body 402 of the composite sutureneedle 400 through tissue during a suturing operation.

Referring to FIGS. 13A and 13B, in one embodiment, the elongated body402 preferably has a proximal body section 420 having a distal end 422,a distal body section 424 having a proximal end 426, and a highlyelastic connector 428 that interconnects the distal end 422 of theproximal body section 420 and the proximal end 426 of the distal bodysection 424. The highly elastic connector 428 may include a mechanicalconnecting structure such as a dovetail-shaped structure for connectingthe highly elastic connector with the proximal and distal body sections420, 424. In one embodiment, the highly elastic connector 428 preferablyhas an outer diameter OD₉ that substantially matches the outer diametersOD₁₀ of the respective proximal and distal body sections 420, 424 thatbound the ends of the highly elastic connector 428.

In one embodiment, the composite suture needle 400 preferably includesthe highly elastic connector 428, which preferably has a higher level ofelasticity than the material used to make the proximal and distal bodysections 420, 424 of the elongated body 402 of the composite sutureneedle 400. In one embodiment, the highly elastic connector 428 may bemade of a highly elastic material, such as nitinol, and the elongatedbody 420 including the proximal and distal body sections 420, 424 may bemade of stainless steel.

In one embodiment, the highly elastic connector 428 at the midsection425 of the composite suture needle 400 preferably defines a more elasticregion of the elongated body 402, which is designed to flex when beingpassed through a cannula without being plastically deformed. Due to thepresence of the more elastic midsection 425 formed by the highly elasticconnector 428, after the composite suture needle 400 is removed from anend of the cannula (e.g., at a surgical site), the elongated body 402 ofthe composite suture needle 400 will desirably return (e.g., springback) to its normal, semi-circular shaped configuration so that thecomposite suture needle 400 may be used for suturing tissue.

Referring to FIG. 14A, in one embodiment, a composite suture needle 500may have a structure that is similar to that shown in described above inthe embodiments of FIGS. 4A-4D, 9A-9D, and/or 12A-12B. In oneembodiment, the composite suture needle 500 preferably includes anelongated body that extends from a proximal end 506 having a sutureattachment barrel 508 that defines a proximal-most end of the compositesuture needle and a distal end 510 having a tapered region 512 with asharpened tip 514 that defines a distal-most end of the composite sutureneedle 500. In one embodiment, the suture needle 500 preferably includesa bendable or highly elastic region 525 that preferably extends along amajority of the length of the elongated body.

Referring to FIG. 14B, in the embodiment, the highly elastic region 525of the composite suture needle 500 preferably includes the elongatedbody 502 made of a less elastic material such as stainless steel, and anouter sheath 530 that surrounds the elongated body, which is made of amore elastic material such as nitinol. In one embodiment, the outersurface of the composite suture needle 500 may have the appearance of anormal, stainless steel needle.

In one embodiment, the needle shown and described above in FIGS. 14A and14B may be transformed from a semi-circular of half-circle shapedconfiguration (FIG. 14A) to a bent configuration having a seagull shape.Referring to FIGS. 15A and 15B, in one embodiment, the composite sutureneedle 500 may be bent along the highly elastic region 525 to providethe needle with a seagull shaped configuration. In the seagull shapedconfiguration of FIGS. 15A and 15B, the suture needle 500 preferably hasa smaller height or lower profile than the suture needle in the unbentconfiguration shown and described above in FIG. 14A. The highly elasticregion 525 is preferably more bendable and less rigid than the proximalend 506 and the distal end 510 of the composite suture needle 500. Assuch, the proximal and distal ends 506, 510 of the composite sutureneedle preferably maintain their original shape in both the unbentconfiguration (FIG. 14A) and the bent configuration (FIGS. 15A and 15B).

Referring to FIG. 16 , in one embodiment, with the highly elastic region525 of the composite suture needle 500 being bent to place the sutureneedle 500 in the bent, seagull shaped configuration, the suture needle500 may be passed through a cannula 570. In FIG. 16 , the bent compositesuture needle 500 having the seagull shaped configuration defines aheight H₅ that is less than the inner diameter ID₄ of the lumen 572 ofthe cannula 570 so that the bent composite suture needle 500 may beeasily passed through the length of the cannula for reaching a surgicalsite, without damaging the needle or creating an unsafe condition for apatient.

Referring to FIGS. 17A-17C, in one embodiment, a composite suture needle600, having a construction that is similar to that shown and describedabove in FIGS. 4A-4D, 9A-9D, and/or 12A-12B, may include an elongatedbody 602 with a proximal end 606 and a distal end 610 having thesharpened tip 614. The composite suture needle 600 preferably includes ahighly elastic region 625 having a stainless steel core and a moreelastic outer sheath, which enables the elongated body 602 to be bent sothat the tip 614 is adjacent the proximal end 606 of the elongated body.

In the bent configuration shown in FIGS. 17A-17C, the composite sutureneedle 600 may be passed through a cannula to a surgical site. Once thesuture needle 600 has reached the surgical site, a surgeon may usesurgical tools to transform the bent suture needle to an unbent,semi-circular configuration as shown and described herein (e.g., theembodiment of FIG. 14A). Once a suturing operation has been completed atthe surgical site, a surgeon may once again bend the composite sutureneedle 600 at the highly elastic region 625 for reducing the dimensionof the needle to remove the suture needle from the surgical site via acannula.

In one embodiment, the elongated body of the elastic suture needle mayhave a bendable region provided thereon, which facilitates changing theshape and/or configuration of the suture needle to fit through a cannula(e.g., a 5 mm cannula), as disclosed in commonly assigned U.S. patentapplication Ser. No. 16/282,604, filed on Feb. 22, 2019, and U.S. patentapplication Ser. No. 16/282,652, filed on Feb. 22, 2019, the disclosuresof which are hereby incorporated by reference herein.

While the foregoing is directed to embodiments of the present invention,other and further embodiments of the invention may be devised withoutdeparting from the basic scope thereof, which is only limited by thescope of the claims that follow. For example, the present inventioncontemplates that any of the features shown in any of the embodimentsdescribed herein, or incorporated by reference herein, may beincorporated with any of the features shown in any of the otherembodiments described herein, or incorporated by reference herein, andstill fall within the scope of the present invention.

1-21. (canceled)
 22. A composite suture needle comprising: an elongatedbody extending from a proximal end to a distal end, the elongated bodyincluding a distal section with a pointed tip at the distal end thereofand a proximal section extending proximally from the distal section, andan entirety of the elongated body having a partially circular shape; anda sheath extending from a proximal end to a distal end and overlying theproximal section of the elongated body, the sheath including a taperedsection and a continuous section, the sheath comprising a material thatis more elastic than a material of the elongated body, and the pointedtip extending distally beyond the distal end of the sheath.
 23. Thecomposite suture needle as claimed in claim 22, wherein the sheathcomprises a highly elastic material and the elongated body comprisesstainless steel.
 24. The composite suture needle as claimed in claim 23,wherein the highly elastic material comprises nitinol.
 25. The compositesuture needle as claimed in claim 23, wherein the stainless steel isselected from a group of stainless steels consisting of austeniticstainless steels, martensitic-aged (mar-aged) stainless steels, andmartensitic-aged alloys.
 26. The composite suture needle as claimed inclaim 22, wherein the sheath has a lumen that extends from the proximalend to the distal end of the sheath and the proximal section of theelongated body is disposed within the lumen of the sheath.
 27. Thecomposite suture needle as claimed in claim 26, wherein the lumen of thesheath has an inner diameter that is greater than or equal to an outerdiameter of the proximal section of the elongated body.
 28. Thecomposite suture needle as claimed in claim 26, wherein an outer surfaceof the continuous section of the sheath has an outer diameter and anouter surface of the tapered section of the sheath tapers from the outerdiameter of the continuous section to approximately an inner diameter ofthe lumen of the sheath to smooth a transition between the distal end ofthe sheath and the distal section of the elongated body.
 29. Thecomposite suture needle as claimed in claim 22, wherein an outer surfaceof the continuous section of the sheath has an outer diameter and anouter surface of the tapered section of the sheath tapers from the outerdiameter of the continuous section to approximately an outer diameter ofthe distal section of the elongated body to smooth a transition betweenthe distal end of the sheath and the distal section of the elongatedbody.
 30. The composite suture needle as claimed in claim 22, whereinthe elongated body includes a concave surface extending along an insideof a curve of the elongated body and a convex surface extending along anoutside of the curve of the elongated body.
 31. The composite sutureneedle as claimed in claim 22, wherein the sheath is attached via athermal shrink lit process, glued or welded to the elongated body. 32.The composite suture needle as claimed in claim 22, further comprising asuture receiving hole formed in a proximal end of the proximal sectionof the elongated body.